The Medical Diode Laser Hair Removal System is used for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Use on all skin types ( Fitzpatrick I-VI), including tanned skin.

Device Description

Laser parameters and other system features are controlled from the control panel on the console, which provides an interface to the system's micro-controller through an LCD touch-screen. In the handpiece of the machine, the light emitted by each discharge at 808nm.

AI/ML Overview

This appears to be a 510(k) summary for a Medical Diode Laser Hair Removal System. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested details about acceptance criteria, clinical study specifics, and ground truth establishment are not available in this document.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance

This document does not present a formal table of "acceptance criteria" for clinical performance. Instead, it demonstrates "substantial equivalence" to predicate devices, meaning it aligns well with the performance and safety profiles of already cleared devices.

The "performance" discussed is primarily technical compliance with electrical, EMC, and laser safety standards, and matching the intended use of predicate devices.

Acceptance Criteria Category	Reported Device Performance (from the document)
Intended Use	The Medical Diode Laser Hair Removal System is used for permanent reduction in hair regrowth defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin. (This is shared with predicate devices, indicating consistency in intended outcome).
Product Code	GEX (Same as predicate devices)
Regulation No.	21 CFR 878.4810 (Same as predicate devices)
Class	II (Same as predicate devices)
Wavelength	808 nm (Same as one predicate, similar to another's 810nm)
Light/Laser source	Diode (Same as predicate devices)
How supplied	Non-sterile, cleanable (Same as predicate devices)
Fluence (Energy Density)	48 J/cm² (Similar to predicate devices: 40 J/cm² and 6-90 J/cm²)
Rep Rate [Hz]	1-10 Hz (Similar to predicate devices: 1-5 Hz and ≤ 10 Hz)
Pulse Duration [ms]	1-300 ms (Similar to predicate devices: 30-200 ms and Up to 310 ms)
Spot Size	1.44 cm² (1.2 x 1.2 cm) (Similar to predicate devices: 1.20 cm² and 1.92 cm²)
Electrical Safety	Comply with IEC 60601-1, IEC 60601-2-22 (Same as predicate devices)
EMC	Comply with IEC 60601-1-2 (Same as predicate devices)
Laser Safety	Comply with IEC 60601-2-22, IEC 60825-1 (Same as predicate devices)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "No clinical study is included in this submission." Therefore, there is no test set, sample size, or data provenance from a clinical study to report. The evaluation is based on non-clinical (bench) testing and comparison to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no clinical study was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical study was conducted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a laser hair removal system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a laser hair removal system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no clinical study was conducted to establish performance against a clinical ground truth. The "ground truth" equivalent for this submission is regulatory compliance with standards and equivalence to predicate devices.

8. The sample size for the training set

Not applicable, as no clinical study was conducted.

9. How the ground truth for the training set was established

Not applicable, as no clinical study was conducted.

Summary

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Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

Weifang Mingliang Electronics CO., LTD % Mr. Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm. 912, Building#15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China

Re: K200525

Trade/Device Name: Medical Diode Laser Hair Removal System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: February 28, 2020 Received: March 2, 2020

Dear Ray Wang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Colin Kejing Chen Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K200525

Device Name

Medical Diode Laser Hair Removal System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Tab #7 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K200525

Date of Preparation 1.
04/23/2020
Sponsor 2.

Weifang Mingliang Electronics CO., LTD.

No.13426, Yuqing Street, High-tech district, Weifang, Shandong, China

Contact Person: Li MingLiang Position: General Manager Tel: +86-15854424546 Email: 290659723@qq.com

1. Submission Correspondent
  Mr. Ray Wang

Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing City, China, 102401 Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang@believe-med.com

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1. Identification of Proposed Device
  Trade Name: Medical Diode Laser Hair Removal System

Common Name: Powered Laser Surgical Instrument

Model(s): V16

Regulatory Information:

Classification Name: Powered Laser Surgical Instrument

Classification: II;

Product Code: GEX;

Regulation Number: 21 CFR 878.4810;

Review Panel: General& Plastic Surgery;

Intended Use:

Device Description 5.

Identification of Predicate Device 6.
Primary Predicate Device 510(k) Number: K181019 Product Name: Diode Laser System Manufacturer: Guangzhou Huafei Tongda Technology Co., Ltd. Secondary Predicate Device 510(k) Number: K153718 Product Name: Spirit Hair Removal laser Family Manufacturer: ACTIVE OPTICAL SYSTEMS , LTD.
1. Non-Clinical Test Conclusion
  Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device conforms with the following standards:

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IEC 60601-1:2005/A1:2012 Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance;
IEC 60601-2-22:2012, Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment;
IEC 60825-1: 2014, Safety of laser products - Part 1: Equipment classification and requirements.
IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
Software Validation & Verification Test
Clinical Test Conclusion 8.

No clinical study is included in this submission.

Substantially Equivalent (SE) Comparison 9.

	Table 1 General Comparison

ITEM	Proposed Device	Predicate Device K181019	Predicate Device K153718	Remark
Product Code	GEX	GEX/ILY	GEX/ILY	SAME
Regulation No.	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	SAME
Class	2	2	2	SAME
Intended Use	The Medical Diode Laser HairRemoval System is used forpermanent reduction in hairregrowth defined as a long term,stable reduction in the number ofhairs re-growing when measured at6, 9 and 12 months after thecompletion of a treatment regimen.Use on all skin types ( FitzpatrickI-VI), including tanned skin.	The Diode Laser System isintended for hair removal,permanent hair reduction on allskin types (Fitzpatrick skin typeI-VI), including tanned skin.Permanent hair reduction isdefined as the long-term, stablereduction in the number of hairsregrowing when measured at 6, 9,and 12 months after thecompletion of a treatment regime.	The Spirit Hair RemovalLaser Family is generallyintended for dermatologicaluse. The devices arespecifically indicated for hairremoval, permanent hairreduction by using selectivelaser energy.The Spirit Hair RemovalLaser Family is intended foruse on all skin types(Fitzpatrick skin types I-VI),including tannedskin.Permanent reduction inhair regrowth is defined aslong term, stable reduction inthe number of hairs	SAME

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			after the completion of the
			treatment regimen.

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ITEM	Proposed Device	Predicate Device	Predicate Device	Remark
		K181019	K153718
Wavelength	808 nm	808nm	810nm	SAME
Light/Laser source	Diode	Diode	Diode	SAME
How supplied	Non-sterile, cleanable	Non-sterile, cleanable	Non-sterile, cleanable	SAME
Fluence (EnergyDensity) [J/cm2]	48	40	6-90 (Model 918)	SIMILAR
Rep Rate [Hz]	1-10	1-5	≤ 10 (Model 918)	SAME
Pulse Duration[ms]	1-300	30-200	Up to 310 ms (Model918)	SIMILAR
Spot Size	1.44cm2 (1.2 x 1.2 cm)	1.20cm2	1.92 cm2 (12 x 16mm) (Model 918)	SIMILAR

Table 2 Performance Comparison

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Item	Proposed Device	Predicate Device	Predicate Device	Remark
		K181019	K153718
EMC, Electrical and Laser Safety
Electrical Safety	Comply with IEC60601-1, IEC60601-2-22	Comply with IEC 60601-1,IEC 60601-2-22	Comply with IEC 60601-1,IEC 60601-2-22	SAME
	EMC	Comply with IEC60601-1-2	Comply with IEC60601-1-2	Comply with IEC60601-1-2	SAME
		Laser Safety	Comply with IEC60601-2-22, IEC 60825	Comply with IEC60601-2-22, IEC 60825	Comply with IEC60601-2-22, IEC 60825

Table 3 Safety Comparison

Analysis

The proposed device has similar indication for use with predicate devices, the main differences are output parameters, such as spot size, fluence, frequency range, pulse duration.

10. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.